- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Lundbeck (Waco, TX)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Lundbeck (Joliet, IL)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials and creation of regulatory submission… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... in quality management in the pharmaceutical industry and quality (GxP) requirements Experience with process mapping, process redesign and SOP authoring/coordination… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical ... personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP...have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager .Regulatory ... the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support,...the meeting minutes. This position develops awareness of global requirements through support of global submissions and this position… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to ... candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... etc.Remain on the cutting edge of data readouts (consistent with FDA -approved labeling), medical congress meeting outputs and podium & symposia… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... area need in terms of program development and propose/implement solutions. Requirements Bachelor's degree in computer science or related field required.Must have… more
- Macpower Digital Assets Edge (Los Angeles, CA)
- …to evolving consumer needs. About the Role: As the Senior Regulatory Affairs Manager , you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, ... and launch. Maintain adherence to company ingredient policies and applicable regulations ( FDA , Health Canada, EPA, etc.). Review and approve product claims, ensuring… more
- IntePros (Mahwah, NJ)
- Project Manager , Engineer - Onsite- NJ Our client, one of the leading medical device companies in the world is seeking a senior PM to support two new product ... equipment based on analysis of specifications, reliability and regulatory requirements . *Support capital acquisition activities. *Develop and model product costing… more
- Walgreens (Redmond, WA)
- Walgreens Registered Manager Local Specialty 1645072BR Job Description Job Summary Responsible for directing the operation of a Walgreens Local Specialty Pharmacy, ... growing the business at the site. Performs all duties of the Pharmacy Manager in their absence . Customer Experience Ensures that store personnel provide hospitable… more
- BioSpace (Tarrytown, NY)
- Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with ... from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s)… more
- See's Candy Shops, Inc. (South San Francisco, CA)
- …passionate about providing great customer service. Job Description Summary: The Senior Manager , Sanitation is a key leadership role responsible for the strategic ... audit readiness and compliance with company and third-party standards (eg, SQF, FDA ). Lead sanitation readiness and participation in internal and external audits,… more
- Revolution Medicines (Redwood City, CA)
- …This role is responsible for ensuring compliance with global regulatory requirements , industry standards, and company policies related to supplier oversight. This ... for GxP vendors aligned with RevMed SOPs, and global regulatory requirements . Establish a risk-based process/framework to plan, conduct audits, qualifications, and… more
- Biotronik (Lake Oswego, OR)
- …to perform job duties. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements , Company policies, operating procedures, ... Territory Manager , Neuro - Detroit, Michigan At BIOTRONIK Neuro,...be able to abide by medical facility mandated PPE requirements due to environmental exposures Must be able to… more
- Coregistics (Acworth, GA)
- Quality Manager Position Summary: The Quality and Operations Manager will be responsible for overseeing and managing the quality control and food safety systems ... enforce policies and procedures to meet federal, state, and local regulations ( FDA , USDA, and other applicable food safety laws), industry standards, and customer… more
- dsm-firmenich (Exton, PA)
- …& patent filings. Execute the job within the applicable DSM, OSHA, EPA, ISO, FDA , CE, & other requirements . We Bring: A competitive compensation package, with ... Manufacturing Engineering Manager Exton, PA (On-Site) The Manufacturing Engineering ...and review project plans, cost estimates, schedules, and resource requirements . Lead Manufacturing Reviews of new products and process… more
